SaMD Diabetes Software Experts

The What, Why, and How of Diabetes-Tech Interoperability

In today’s market, diabetes technology needs to come with a high degree of interoperability. In this article, we look at what interoperability is, why it is so important, and how you can create software and devices readymade to connect.

The ability of different medical devices to work together brought us the first artificial pancreas. And with that, the undeniable fact that interoperability is the future of diabetes management.

But interoperability just between related devices produced by the same company is too limited to realize the full potential of this world. In order to foster true innovation, companies must work together to create highly customizable interoperable systems.

In this article, we’ll take a closer look at what interoperability is and why it is so important, and how companies can overcome the many obstacles of inter-organizational interoperable systems to help realize the full potential of this technology. 

What Is Interoperability?

In its most basic form, interoperability is the ability of two devices to exchange information and put that exchanged information to use.

The first widely available artificial pancreas (AP), for example, comprised an insulin pump capable of receiving and reacting to data taken from a connected continuous glucose monitor (CGM). This data exchange and interpretation relied on an algorithm—the third piece in the puzzle. Each one of these parts was developed by the same company.

Today, we have multiple AP devices on the market. Some comprise parts made by a single company and some consist of interoperable pieces made by separate companies.

Even as more diabetes technology companies open their minds to working with one another, the restricted nature of these partnerships continues to hinder the potential of interoperable diabetes tech.

Why Is Achieving Interoperability So Important (and Difficult)?

The true potential of this type of technology cannot be realized until it becomes commonplace to create devices capable of communicating and reacting to most other devices in that market.

Creating an AP that comprises multiple options for CGMs, algorithms, and insulin pumps gives the user the ability to choose the exact device makeup that is right for them. Some users may prefer algorithms with a focus on preventing lows, while others may be more attracted to algorithms built to keep blood sugars as close to normal as possible. Users from both groups are likely to have different opinions as to what type of pump works better for their lifestyle and which CGM is more accurate.

With a truly interoperable market, each user would be able to cherry-pick the parts of the whole that are right for them. And by doing so, they would be more likely to achieve healthy blood sugar levels and less likely to suffer from complications.

This same principle applies to all types of interoperable diabetes technology, from data sharing platforms to smart insulin pens.

For the end-user, a world of true interoperability is the dream. But for the companies responsible for creating diabetes tech, it can be a difficult process. 

Interoperability carries its own unique risks and hurdles during creation and manufacture. Not to mention the many headaches associated with getting interoperable devices cleared by regulatory bodies.

But more than anything, the biggest hindrance to developing this kind of technology is that it requires companies to be just as invested in the devices created by other companies as those they are developing themselves.

Hurdles to Intercompany Interoperable Device Development

In order to create diabetes devices that are interoperable with technology created by one or more other companies, each organization must be willing to work together throughout the entire development process.

At each stage in this process, there are hurdles that must be overcome.

During the development and engineering of new products, each company must adhere to a common standard shared by all partners. This process, especially, requires a huge degree of communication. If one partner experiences problems in development, it will affect how each proceeds with their product. 

Developing new products based on an established standard provides a guide for all known and future partners to follow in order to assure compatible products. While some rudimentary standards have been established, such as those created by IEEE, most industry-wide standards are too vague to be effective. In many cases, standards must be developed and agreed upon by those creating that specific system. Differences in priorities between companies can make this process and the long-term adherence to established standards difficult.

Beyond established standards for the development of new technology, interoperable devices must also share common technology or IP. This is important for reducing variability between components and assuring all pieces continue to function together seamlessly. How easy it is for partners to agree on and implement a common technology or IP depends on existing corporate culture and management differences.

Product testing can be another sticking point in the development of interoperable tech. Not only must each piece function perfectly on its own, but it must be tested to assure it works with every other component. This is a far more complex process than testing a standalone device because the usage scenarios are far more wide ranging.

The need for constant communication and synchronized development does not end when the products hit the market. Post-market surveillance is key for interoperable devices to assure they continue to work as intended as updates and bug fixes are implemented. Issues discovered during this process will require further communication to assure any fixes or recalls are done in tandem and cover all necessary parts.

The Need for a Neutral Third-Party Partner

It is difficult enough for one company to develop and build a highly advanced medical device or software. Creating and building multiple highly advanced technologies across multiple companies seems nearly impossible.

Spending too much time focusing on your own tech will invariably lead to issues with timing and compatibility between devices during the final rollout. Pay too much attention to what your partner companies are doing, and you may end up being the one with the problematic device.

So how do you work with multiple other companies to create a truly interoperable system without sacrificing the integrity of your own product or risking the compatibility of the entire system? The answer is in a neutral third-party partner.

Sequenex works as the go-between to unite partners and technology in the pursuit of multi-company, interoperable systems.

We create modular and flexible software frameworks that accelerate the development and delivery of innovative interoperable diabetes products. And, we make sure the processes are standardized and align to relevant Quality standards, such as ISO13485 and IEC62304. By overseeing the project as a whole, we free each partner up to supervise the creation of their own technology. We allow you to focus on the tech that makes your product great while we focus on the complexities that will allow that product to interact seamlessly with the larger interoperable system.

To learn more about our services and what we can do for you, visit our website or contact us today.

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